27/20. Fostemsavir  - (July 2020)- To treat  HIV 

PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Hypersensitivity Reactions- Inform patients that if they have had a hypersensitivity reaction to RUKOBIA or any of its components, they should not take RUKOBIA .

Immune Reconstitution Syndrome- Advise patients to inform their healthcare provider immediately of any signs and symptoms of infection, as inflammation from previous infection may occur soon after combination antiretroviral therapy, including when RUKOBIA is started.

QTc Interval Prolongation- Advise patients that RUKOBIA may produce changes in their electrocardiogram (i.e., QT prolongation).

Instruct patients to consult their healthcare provider if they experience symptoms such as dizziness, lightheadedness, abnormal heart rhythm, or loss of consciousness.

Patients with Hepatitis B or C Virus Co-infection- Advise patients that it is recommended to have laboratory testing and to take medications for HBV or HCV as prescribed.

Drug Interactions- RUKOBIA may interact with other drugs; therefore, advise patients to report to their healthcare provider the use of any other prescription or nonprescription medication or herbal products, including St. John’s wort .

Pregnancy Registry- Inform patients that there is an antiretroviral pregnancy registry to monitor fetal outcomes in those exposed to RUKOBIA during pregnancy.

Lactation- Instruct mothers with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in the breast milk .

Potential Odor of Tablets RUKOBIA tablets may have a slight vinegar-like odor.

Missed Dosage- Advise patients to avoid missing doses as it can result in development of resistance. Instruct patients that if they miss a dose of RUKOBIA, to take it as soon as they remember.

Advise patients not to double their next dose or take more than the prescribed dose.

Trademark is owned by or licensed to the ViiV Healthcare group of companies. Manufactured for: ViiV Healthcare Research Triangle Park, NC 27709 by: GlaxoSmithKline Research Triangle Park, NC 27709